Statement on Clinical Trials, Research and WaPo Article

Washington, D.C. (November 26, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani issued the following statement today:

“The Washington Post story ‘Can Drug Research Still Be Trusted?’ presents a one-sided view of the critically important scientific endeavors that explore and ultimately discover and produce life-saving innovative medicines. The article is based upon the unfounded assumption that any industry funding of clinical research inherently leads to a conflict of interest and thus bias in results. It presumes such inherent bias does not exist when funding is provided by other sources, such as government or academic institutions.

“The narrow focus on industry funding as the sole source of potential conflicts of interest is unfortunate and unwarranted, and tarnishes the important role that the biopharmaceutical industry plays in driving innovation and bringing treatments forward to address unmet medical needs. While potential for bias in research may exist regardless of the source of funding, all researchers whether in academia or industry should not be presumed to be anything but devoted to generating the best scientific findings. For example, academic researchers are rewarded based on publishing in reputable scientific journals such as the New England Journal of Medicine and National Institutes of Health (NIH) grants are awarded based on publishing track records among other criteria. Experts are sought out by top tier academic institutions, industry and regulators based on their body of work.

“PhRMA member companies are in fact the leading force in research into potential new medicines and cures, investing approximately $50 billion on R&D in 2011. PhRMA member companies have invested over $500 billion on R&D since 2000. The National Science Foundation found that the biopharmaceutical sector accounts for the single largest share of all U.S. business R&D, representing nearly 20% of all domestic R&D funded by U.S. businesses. The Congressional Budget Office has said, ‘The pharmaceutical industry is one of the most research-intensive industries in the United States. Pharmaceutical firms invest as much as five times more in research and development, relative to their sales, than the average U.S. manufacturing firm.’

“However, no individual actor, either private or public, has all the human resources and expertise in one place required to achieve success in developing new treatments. Thus, clinical research is conducted in a diverse scientific ecosystem that features companies, government entities such as the NIH, academic research institutions, hospitals, physicians, healthcare professionals and of course the many patients who volunteer to participate in clinical trials. All of these partners are critical to the eventual findings. The difficult and evolving nature of scientific discovery demands that all parties use all available knowledge and resources to continue medical progress and deliver new care options for patients. In fact, the biopharmaceutical sector is striving to increase collaborations with academia to ensure the best research is conducted, while unfortunately some academic institutions have sought to limit their partnerships, which does not help patients.

“Clinical research is in-part advanced by the good intentions of all who contribute to it and operate under strict ethical and legal requirements. An elaborate system of safeguards is in place, including blinding of trials, oversight by institutional review boards, independent data safety monitoring committees, regulatory agencies, editorial peer review and post-marketing surveillance. This system of checks and balances is focused on protecting patients’ safety and privacy and the integrity of clinical trials regardless of who funds and who conducts the research. For the overwhelming majority of research, the process works well. Where it has not, issues have been addressed to advance and improve this state of the art system.

“The biopharmaceutical industry is perhaps the most transparent research-based industry in the world. PhRMA member companies take great care to respect and protect the safety and individual privacy of research participants and have a longstanding commitment to sponsoring clinical studies that fully comply with all legal and regulatory requirements. By committing to PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, member companies help to ensure their clinical research is scientifically and ethically rigorous, and that clinical trial results are properly communicated to healthcare professionals, patients, and the public.

“At the beginning of every clinical trial involving patients, biopharmaceutical companies provide information about testing of new treatments on a searchable U.S. government website (ClinicalTrials.gov), so that eligible patients seeking new cures may decide to participate in clinical research. Following FDA approval, biopharmaceutical companies place the results of the clinical trials FDA relies upon for approving new medicines on the same government web site for all to examine. In 2009, the PhRMA Principles were further strengthened, with biopharmaceutical companies agreeing to voluntarily place online the results from clinical trials of discontinued research programs in the hope that others may benefit from these findings, even if a company will not move forward with them. No other industry posts the basic research for its marketed and discontinued products online for all to see.

“As of November 2012, patients, physicians, and the public could visit ClinicalTrials.gov and learn about over 135,000 clinical trials. Since 2007, when the industry supported legislation to require posting research results for newly approved medicines, biopharmaceutical companies had already posted results from over 7,300 clinical trials.

“Importantly, even in the most carefully conducted trial, there are findings that will only be discovered after the medicine reaches the market and is used by hundreds of thousands or millions of patients. Thus biopharmaceutical companies are also committed to post-marketing research and reporting of potential new findings on medicines after they have become commercially available. More information about clinical trials can also be found at www.phrma.org/innovation/clinical-trials.

“At the same time that the Washington Post criticized the industry for biasing results simply by collaborating with research partners and providing funding to scientists, the New York Times published a glowing profile of Dr. Robert Langer and the Langer Lab at the Massachusetts Institute of Technology (MIT). The Langer Lab which spawned numerous companies and hundreds of patents, demonstrating the value of effective collaboration between industry and academy. According to the article, Dr. Langer serves on the boards of 12 companies and as a consultant to large biopharmaceutical companies. The article also discusses how MIT addressed the potential for conflicts of interest, showing how the checks and balances work at the most rigorous institutions.

“It is ironic that the bias the Washington Post assumes in the biopharmaceutical research ecosystem is reflected in its own story, which begins from a false premise, quotes extensively from noted industry critics to prove its own desired conclusion and omits significant evidence that demonstrates the ethical rigor of biopharmaceutical research. A fully informed and candid conversation about the valuable interaction between industry and the other members of the ecosystem in the development of new medicines would be a useful exercise that can further our scientific knowledge. A sensationalized article built on repackaging limited and already known information to provide a skewed view of biopharmaceutical research does not.

“The biopharmaceutical sector is proud of our commitment to science and the over 300 new medicines that have been approved over the last decade – and the 3,200 in the pipeline today. We are also proud of our commitment to transparency and collaboration to advance biomedical innovation. We will continue to work toward the most effective and efficient research process that supports all participants in the ecosystem and most importantly, provides safe and effective medicines to patients in need."

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines.